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First introduced in 1997, the 21 CFR (Code of Federal Regulations) Part 11 is a complex and comprehensive set of legislation developed by the U.S. Food and Drug Administration (FDA) that describes the controls necessary for the 30-billion-dollar regulated pharmaceutical, biotechnology, medical/laboratory device, and life sciences industries.

Although 21 CFR Part 11, herein referred to as "Part 11" does not specify any type of instrument, system, or technology to be used, it does apply to all systems, instruments, applications, and operations that save data electronically.

In its essence, Part 11 provides guidance on how the industry must handle electronic records ("e-records") and electronic signatures ("e-sigs"). Part 11 also details the circumstances under which the FDA will allow e-records and e-sigs to be considered equivalent substitutes for non-electronic records, handwritten signatures, paper records, and various forms of film.

This aspect of Part 11 aligns closely with the Electronic Signatures in Global and National Commerce Act (ESIGN) act, which we discuss elsewhere in this report.

The 15-20 years following the original release of the Good Manufacturing Practices (GMP) in 1978 have seen the life sciences and pharmaceutical industries transform themselves from a reliance on paper, notebooks and chemical formulas scribbled on notes to a heavy dependence on computer systems and electronic storage.

Once the transition to a digital environment begins, it tends to gather momentum rapidly, and accordingly, the life sciences industry has quickly become one of the leading producers of digital information.

Although the GxPs have not changed for nearly 25 years, the life sciences industry has been altered dramatically. In recognition of that change, the FDA now realizes that it needs to revise the GMP, and deliver a GMP for the 21st Century.

The most significant change in the life sciences and pharmaceutical industries over the past 25 years has been the transition to a digital/electronic environment. As such, Part 11 was introduced in 1997 to address the increased use of electronic records and signatures because the original GMP only addressed paper and ink (or film) records.

The evolving 21st century GMP is being shaped by recent changes in FDA personnel and the FDA's attitude towards ensuring compliance. It is also being shaped by how the FDA is assessing the interpretation and enforcement of Part 11, given its belief that the GMP and Part 11 are complementary.

(See chart 21 for the key market drivers and storage requirements impacting the life sciences industry.)

The above information was excerpted by permission from the Enterprise Storage Group executive summary to the research report, "Compliance: The effect on information management and the storage industry," published in May 2003. To learn more about the full report, contact the Enterprise Storage Group.

Copyright 2003, Enterprise Storage Group

Peter Gerr is a senior research analyst at the Enterprise Storage Group. He will be speaking about the IT impact on compliance legislation at Storage Decisions 2003.

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